Mizoram Drug License
Mizoram Drug License
Drug license is a permit granted by the government under the Drugs and Cosmetics Act 1940 to deal with drugs. There are two kinds of licenses namely retail license and wholesale license that is mandatory for drug distribution or sale in India. The license is issued after the verification of certain requirements pertaining to the premises and the person dealing with drugs.
Drug Regulation
Drug Regulation is a system to monitor and protect the public health, by controlling the safety and efficacy of the products in areas like pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Regulatory Process for Approval of a New Drug
An application to conduct clinical traits in India has to be submitted along with the data of chemistry, animal studies to DCGI and to the manufacturing control. The date regarding the trial protocol, informed consent documents and investigator’s brochures have to be attached. A copy of the application should be submitted to the Ethical Committee. Only after the approval of DCGI and the Ethical Committee, the clinical trials are conducted.
Features of Drug License
The basic features of a drug license are listed below:
- Mandatory for drugs and cosmetics business.
- Drug license is granted in commercial premises for the sale of medicines and cosmetics.
- Pharmacy business has to abide by all the conditions of the license.
- Drug license is displayed at a noticeable place of the premises.
Classification of Drug License
Drug licenses are classified into three categories. They are
- Manufacturing License
- Sale License
- Loan License
Manufacturing License
Manufacturing license is required for manufacturing allopathic/ Homeopathic medicines and cosmetics and to repack drugs. This license is issued only in recognized industrial areas.
Sale License
Sale license is required to sell drugs to the customers. This license is further classified as
- Retail Drug License
- Wholesale Drug License
Loan License
Loan license is issued to an individual who intends to avail the manufacturing facilities owned by another licensee. If a pharmacy business is run in more than two states, then this license has to be obtained in every place where the business is carried on.
Mizoram Drug Law
The State Assembly has passed a Mizoram Drug (Controlled Substances) Bill in the year 2016 to seize and prosecute people possing and selling drugs including the drugs that are commonly abused pharmaceutical drugs. The bill does not conflict with any existing drug law in India but includes certain provisions to suit the local drug problems. The law ensures the simplification of procedures to elevate the rate of conviction including the manufacture, sale, use, abuse and treatment that are listed in the pharmaceutical drugs. Moreover, the law provides quality in the treatment of addicts establishment of treatment cum rehabilitation centres.
Infrastructure Requirements
To establish a medical shop or a pharmacy, a minimum of 10 square meters is required. Store business combination with retail and wholesale, a minimum of 15 square meters is required.
Storage Requirements
It is mandatory to have a refrigerator and an air conditioner on the premises because certain drugs such as vaccines, insulin injections, etc have to be stored in the fridge.
Technical Staff
Online Sale: Online sale of a drug is possible only when there is a registered pharmacist is present who is approved by the concerned department. The pharmacist has to be present throughout the working hours in the retail shop.
Wholesale: Wholesale of drugs can be made either by a registered pharmacist or by another person who has to be a graduate with one year experience in drugs or the person has to pass S.S.L.C with four years experience in drugs who is specially approved by the drug control department.
Importing Drug in India
Requirements to import rugs in India as specified in Schedule X and those drugs that are not specified in schedule require an Import License. If more than one drug is manufactured by the same manufacturer, a single license may be issued. A manufacturer having more than two factories manufacturing drugs in different places, a separate license will be required for each factory.
Application Procedure
The application procedure for the grant of selling license is given below.
Step 1: Obtain the Application
The applicant has to fill the required Forms 19, 19A,19B, 19AA.
Step 2: Fee Payment
The applicant has to remit the required fee.
Step 3: Inspection
The concerned officials survey the application and inspect the premises.
Step 4: Grant of License
If all the requirements have complied, the authority issues the license.
Documents Required
- Duly filled Application Form.
- Fee receipt or challan, as the case may be or their attested copies.
- 3 copies of the layout of the selling premises.
- Documents like rent receipt, purchase documents or its attested copies that mentions the lawful possession of the premises.
- Documents pertaining to the constitution of the firm like Memorandum, Partnership-deed, and article of association etc.
- Details of the competent technical staff / registered people with copies of experience, educational qualification and registration certificates.
- Full name of the partners or the proprietors, as the case may be has to be mentioned in the application. For private or public limited concerns, the full name of the Directors who signs the application and the authorised signatory, if any, has to be provided in the application form.
- Documents for the purchase of Deep freezer/ Refrigerator (For Vaccines / Sera).
Renewal of Drug License
The procedure for renewing the sale of drug license is given below.
Step 1: Obtain the Application
The applicant has to fill the required Forms 19, 19A, 19AA, 19B, 19C.
Step 2: Fee Payment
The applicant has to remit the required fee.
Step 3: Inspection
The concerned officials survey the application and inspect the premises.
Step 4: Grant of License
If all the requirements have complied, the authority issues the license.
Documents Required
The following are the documents required to renew the license required for selling drugs.
- Copy of cash receipt or challan for payment of fees.
- Xerox copy of Licence or the previous renewal certificate.
- Documents such as the rent receipt, purchase documents or its attested copies showing lawful possession of the premises.
- Details of the competent technical staff/ registered people along with copies of their educational qualification, experience and registration certificates.
